Below are the most recent publications written about "Drug Labeling" by people in Profiles.
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de Leon J, Baldessarini RJ, Balon R, Bilbily J, Caroff SN, Citrome L, Correll CU, Cotes RO, Davis JM, DeLisi LE, Faden J, Freudenreich O, Goldsmith DR, Gurrera R, Josiassen RC, Kane JM, Kelly DL, Keshavan MS, Laitman RS, Lam YWF, Leung JG, Love RC, McCollum B, McGrane IR, Meyer JM, Nasrallah HA, Nucifora FC, Rothschild AJ, Rubio JM, Sajatovic M, Sarpal DK, Schoretsanitis G, Shad M, Shelton C, Sher L, Singh B, Surya S, Zarzar TR, Sanz EJ, De Las Cuevas C. Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II: A Review of Fatal Outcomes in US Pharmacovigilance Data and Proposed Changes. J Clin Psychopharmacol. 2025 May-Jun 01; 45(3):197-218.
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de Leon J, Baldessarini RJ, Balon R, Bilbily J, Caroff SN, Citrome L, Correll CU, Cotes RO, Davis JM, DeLisi LE, Faden J, Freudenreich O, Goldsmith DR, Gurrera R, Josiassen RC, Kane JM, Kelly DL, Keshavan MS, Laitman RS, Lam YWF, Leung JG, Love RC, McCollum B, McGrane IR, Meyer J, Nasrallah HA, Nucifora FC, Rothschild AJ, Rubio JM, Sajatovic M, Sarpal DK, Schoretsanitis G, Shad M, Shelton C, Sher L, Singh B, Surya S, Zarzar TR, Sanz EJ, De Las Cuevas C. Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I: A Review of the Pharmacokinetic Literature and Proposed Changes. J Clin Psychopharmacol. 2025 May-Jun 01; 45(3):179-196.
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Prado G, Svoboda RM, Teplitz RW, Farberg AS, Rigel DS. Patient knowledge of FDA-mandated sunscreen labeling terminology: A cross-sectional survey. Photodermatol Photoimmunol Photomed. 2019 May; 35(3):141-147.
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Kane-Gill SL, Dasta JF, Buckley MS, Devabhakthuni S, Liu M, Cohen H, George EL, Pohlman AS, Agarwal S, Henneman EA, Bejian SM, Berenholtz SM, Pepin JL, Scanlon MC, Smith BS. Clinical Practice Guideline: Safe Medication Use in the ICU. Crit Care Med. 2017 Sep; 45(9):e877-e915.
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Psotka MA, von Maltzahn R, Anatchkova M, Agodoa I, Chau D, Malik FI, Patrick DL, Spertus JA, Wiklund I, Teerlink JR. Patient-Reported Outcomes in Chronic?Heart Failure: Applicability for Regulatory Approval. JACC Heart Fail. 2016 10; 4(10):791-804.
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Shah YD, Singh K, Friedman D, Devinsky O, Kothare SV. Evaluating the safety and efficacy of felbamate in the context of a black box warning: A single center experience. Epilepsy Behav. 2016 Mar; 56:50-3.
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Fantasia HC, Harris AL. Changes to Pregnancy and Lactation Risk Labeling for Prescription Drugs. Nurs Womens Health. 2015 Jun-Jul; 19(3):266-70.
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Lu CY, Zhang F, Lakoma MD, Madden JM, Rusinak D, Penfold RB, Simon G, Ahmedani BK, Clarke G, Hunkeler EM, Waitzfelder B, Owen-Smith A, Raebel MA, Rossom R, Coleman KJ, Copeland LA, Soumerai SB. Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study. BMJ. 2014 Jun 18; 348:g3596.
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Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 08; 6(218):218ra5.
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Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, Shoaibi A, Gurwitz JH. Response to the letter by Mol. Pharmacoepidemiol Drug Saf. 2014 Jan; 23(1):106.